23andMe and the FDA

In 2013, 23andMe received a warning letter from the US Food and Drug Administration (FDA) to discontinue marketing its health-related genetic tests in the United States until it completed the agency’s regulatory review process. We complied with that request and subsequently, and until October 2015, provided only ancestry reports and raw data to customers who purchased the service.

The new 23andMe experience, launched in October 2015, reflects almost two years of work with regulators, our scientists, medical experts, and product designers. The result is the first and only genetic service available directly to individuals in the United States that includes reports that meet FDA standards for being scientifically and clinically valid. 23andMe will continue to seek FDA authorization to offer new reports.

On April 6, 2017, 23andMe was granted authorization by the FDA to market Late-Onset Alzheimer's Disease, Parkinson's Disease and Hereditary Thrombophilia genetic health risk reports along with other reports. We will release the first set of new genetic health risk reports including late-onset Alzheimer’s Disease, Parkinson’s Disease, Hereditary Thrombophilia, Alpha-1 Antitrypsin Deficiency, and a new carrier status report for Gaucher’s Disease in April, with additional reports to follow. If you purchase our Health + Ancestry Service today, you will get them for free when they are ready. Current 23andMe customers will be notified directly on their eligibility for receiving new genetic health risk reports.